FDA Adverse Event
Injury
Summary report: N
VIRTUOSO VR
MDR report key: 1922170
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05880
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 13, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE HIGH LEAD IMPEDANCE AND OVER SENSING REPORTED BY THE SUBMITTER WAS CONFIRMED AND WAS SHOWN TO BE CAUSED BY A FAULTY TANTALUM CAPACITOR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS UNDERSENSING, OVERSENSING, HAD HIGH IMPEDANCE, LOSS OF CAPTURE, NO PACING OUTPUT AND NOISE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUOSO VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154VWC | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | 6944 IMPLANTABLE TACHY LEAD |